This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Inspra (Eplerenone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (68)
Death (3)
Life Threatening Events (3)
Reports by Reaction Type
Renal Failure Acute (9),
Dyspnoea (8),
Renal Failure (7),
Drug Interaction (5),
Nausea (5),
Hyponatraemia (5),
Hypertensive Crisis (5),
Dizziness (4),
Blood Creatinine Increased (4),
Blood Pressure Increased (4),
Glomerular Filtration Rate Decreased (4),
Blood Potassium Increased (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Inspra (Eplerenone). For a complete list or a specific selection of reports, please use the links above.
Possible Inspra side effects in 79 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22
Patient: 79 year old male, weighing 66.7 kg (146.7 pounds)
Reactions: Rash Generalised, Skin Exfoliation, Rash Erythematous, DRY Skin
Drug(s) suspected as cause:
Inspra
Other drugs received by patient: Bumetanide; Levothyroxine; Ramipril; Warfarin; Simvastatin
Possible Inspra side effects in 84 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01
Patient: 84 year old male
Reactions: Aortic Stenosis, Pain, Wound, Orthostatic Hypotension, Tricuspid Valve Calcification, Fall, Aortic Valve Calcification, Malaise, Injury
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Eupressyl
Dosage: 60 mg, 1x/day
Administration route: Oral
Start date: 2011-01-01
End date: 2012-06-08
Inspra
Dosage: 25 mg, 1x/day
Administration route: Oral
Start date: 2011-01-01
End date: 2012-06-08
Other drugs received by patient: Atorvastatin; Lasix; Perindopril Erbumine; Temerit; Amlodipine Besylate; Plavix; Aspirin
Possible Inspra side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-31
Patient: 56 year old male
Reactions: Long QT Syndrome
Drug(s) suspected as cause:
Bisoprolol Fumarate
Dosage: oral
Administration route: Oral
Inspra
Indication: Product Used FOR Unknown Indication
Procolaran (Ivabradine)
Indication: Product Used FOR Unknown Indication
Simvastatin
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Inspra side effects in 56 year old male
Reported by a physician from Germany on 2012-07-13
Patient: 56 year old male
Reactions: Long QT Syndrome
Drug(s) suspected as cause:
Bisoprolol Fumarate
Inspra
Ivabradine
Simvastatin
Possible Inspra side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: male
Reactions: Cardio-Respiratory Arrest, Fall, Asthenia, Renal Failure Acute
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Inspra
Dosage: 25 mg, daily
Administration route: Oral
Revatio
Dosage: 20 mg, 3x/day
Administration route: Oral
Other drugs received by patient: Potassium Chloride; Coumadin; Colace; Flovent; Duoneb; Coreg; Mucinex; Multi-Vitamins; Combivent; Mirtazapine; Wellbutrin; Prilosec; Aspirin; Lisinopril; Simvastatin; Ascorbic Acid; Novolog; Prozac; Lantus
Possible Inspra side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-29
Patient: male
Reactions: Cardio-Respiratory Arrest, Asthenia, Fall, Renal Failure Acute
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Inspra
Dosage: 25 mg, daily
Administration route: Oral
Revatio
Dosage: 20 mg, 3x/day
Administration route: Oral
Other drugs received by patient: Prilosec; Coreg; Novolog; Combivent; Wellbutrin; Mirtazapine; Lisinopril; Flovent; Aspirin; Duoneb; Coumadin; Prozac; Multi-Vitamins; Ascorbic Acid; Simvastatin; Colace; Lantus; Potassium Chloride; Mucinex
Possible Inspra side effects in
Reported by a physician from Netherlands on 2012-06-22
Patient:
Reactions: Renal Failure
Drug(s) suspected as cause:
Inspra
Possible Inspra side effects in 70 year old female
Reported by a consumer/non-health professional from Germany on 2012-06-19
Patient: 70 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Inspra
Dosage: 50 mg, unk
Indication: COR Pulmonale
Start date: 2011-01-01
Inspra
Dosage: 12.5 mg, 1x/day
Indication: Pleural Effusion
Possible Inspra side effects in 70 year old female
Reported by a consumer/non-health professional from Germany on 2012-06-13
Patient: 70 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Inspra
Dosage: 12.5 mg, 1x/day
Indication: Pleural Effusion
Inspra
Dosage: 50 mg, unk
Indication: COR Pulmonale
Start date: 2011-01-01
Possible Inspra side effects in 74 year old male
Reported by a consumer/non-health professional from Venezuela on 2012-06-11
Patient: 74 year old male
Reactions: Dyspnoea, Tracheostomy, Laryngeal Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Inspra
Possible Inspra side effects in 70 year old female
Reported by a consumer/non-health professional from Germany on 2012-06-01
Patient: 70 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: COR Pulmonale, Pleural Effusion
Drug(s) suspected as cause:
Inspra
Possible Inspra side effects in
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient:
Reactions: Renal Disorder
Drug(s) suspected as cause:
Inspra
Dosage: unk
Norvasc
Dosage: unk
Possible Inspra side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: male
Reactions: Blood Pressure Increased, Neuropathy Peripheral, Diabetes Mellitus, Headache
Drug(s) suspected as cause:
Inspra
Possible Inspra side effects in
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient:
Reactions: Renal Disorder
Drug(s) suspected as cause:
Inspra
Dosage: unk
Norvasc
Dosage: unk
Possible Inspra side effects in male
Reported by a consumer/non-health professional from Canada on 2012-05-04
Patient: male
Reactions: Prostatic Specific Antigen Increased, Drug Intolerance, Cognitive Disorder
Drug(s) suspected as cause:
Inspra
Dosage: 25 mg, unk
Indication: Hyperaldosteronism
Start date: 2011-06-01
Inspra
Dosage: 12.5 mg, unk
End date: 2011-10-01
Other drugs received by patient: Vitamin TAB; Androgel; Ginko Biloba
Possible Inspra side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-24
Patient: male
Reactions: Blood Pressure Increased, Diabetes Mellitus
Drug(s) suspected as cause:
Inspra
Possible Inspra side effects in female
Reported by a consumer/non-health professional from NEW Zealand on 2012-04-23
Patient: female
Reactions: Oral Pain, Tongue Disorder, Mouth Ulceration, Oropharyngeal Blistering
Drug(s) suspected as cause:
Inspra
Possible Inspra side effects in female
Reported by a physician from Germany on 2012-04-12
Patient: female, weighing 76.0 kg (167.2 pounds)
Reactions: Aphasia, Thyroid Disorder, Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Dosage: 1 df, qd
Administration route: Oral
Start date: 2011-09-27
Digimerck
Indication: Cardiac Failure
Digimerck
Dosage: 1 df, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2006-12-14
Dogmatil
Dosage: ?-0-? df
Administration route: Oral
Indication: Depression
Start date: 2008-04-21
Inspra
Dosage: 1 df, qd
Administration route: Oral
Indication: Cardiac Failure
Start date: 2005-07-04
Levothyroxine Sodium
Dosage: 1 df, per day
Administration route: Oral
Indication: Thyroid Disorder
Start date: 2011-09-27
Metformin HCL
Dosage: 2 df, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-08-23
Metoprolol Tartrate and Hydrochlorothiazide
Dosage: 0.5 df, bid
Administration route: Oral
Indication: Hypertension
Start date: 2007-04-03
Rasilez
Dosage: 1 df, qd
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-22
Tegretol
Dosage: 2 df, per day
Administration route: Oral
Indication: Depression
Start date: 2011-09-27
Other drugs received by patient: Diuretics; ACE Inhibitor; HMG COA Reductase Inhibitors; Vasodilators; Calcium Channel Blockers; Nitrates; Antihypertensives
Possible Inspra side effects in female
Reported by a physician from Germany on 2012-04-11
Patient: female, weighing 76.0 kg (167.2 pounds)
Reactions: Type 2 Diabetes Mellitus, Thyroid Disorder, Transient Ischaemic Attack
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Digimerck
Dosage: 1 df, per day
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2006-12-14
Digimerck
Indication: Cardiac Failure
Dogmatil
Dosage: 0.25 df, per day
Indication: Depression
Start date: 2008-04-21
Inspra
Dosage: 1 df, per day
Administration route: Oral
Indication: Cardiac Failure
Start date: 2005-07-04
Levothyroxine Sodium
Dosage: 1 df, per day
Administration route: Oral
Indication: Thyroid Disorder
Start date: 2011-09-27
Metformin HCL
Dosage: 2 df, daily
Administration route: Oral
Indication: Diabetes Mellitus
Start date: 2011-08-23
Metoprolol Succinate
Dosage: 0.5 df, per day
Administration route: Oral
Indication: Hypertension
Start date: 2007-04-03
Rasilez
Dosage: 1 df/day
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-22
Other drugs received by patient: Vasodilators Used IN Cardiac Diseases; Calcium Channel Blockers; Nitrates; ACE Inhibitors; Other Antihypertensives; Diuretics
Possible Inspra side effects in female
Reported by a physician from Germany on 2012-04-11
Patient: female, weighing 76.0 kg (167.2 pounds)
Reactions: Aphasia, Thyroid Disorder, Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Dosage: 1 df, qd
Administration route: Oral
Start date: 2011-09-27
Digimerck
Indication: Cardiac Failure
Digimerck
Dosage: 1 df, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2006-12-14
Dogmatil
Dosage: ?-0-? df
Administration route: Oral
Indication: Depression
Start date: 2008-04-21
Inspra
Dosage: 1 df, qd
Administration route: Oral
Indication: Cardiac Failure
Start date: 2005-07-04
Levothyroxine Sodium
Dosage: 1 df, per day
Administration route: Oral
Indication: Thyroid Disorder
Start date: 2011-09-27
Metformin HCL
Dosage: 2 df, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-08-23
Metoprolol Tartrate and Hydrochlorothiazide
Dosage: 0.5 df, bid
Administration route: Oral
Indication: Hypertension
Start date: 2007-04-03
Rasilez
Dosage: 1 df, qd
Administration route: Oral
Indication: Hypertension
Start date: 2008-10-22
Tegretol
Dosage: 2 df, per day
Administration route: Oral
Indication: Depression
Start date: 2011-09-27
Other drugs received by patient: ACE Inhibitor; Calcium Channel Blockers; Antihypertensives; Vasodilators; Nitrates; HMG COA Reductase Inhibitors; Diuretics
Possible Inspra side effects in male
Reported by a physician from Canada on 2012-04-11
Patient: male
Reactions: Prostatic Specific Antigen Increased, Cognitive Disorder
Drug(s) suspected as cause:
Inspra
Possible Inspra side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-11
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Inspra
Dosage: unk
Revatio
Dosage: unk
Possible Inspra side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-10
Patient: male
Reactions: Leukocyturia, Renal Failure Acute
Drug(s) suspected as cause:
Allopurinol
Dosage: 200 mg
Administration route: Oral
Indication: Gout
Start date: 2010-07-31
End date: 2010-10-30
Gentamicin Sulfate
Dosage: 380 mg
Indication: Staphylococcal Sepsis
Start date: 2010-10-31
End date: 2010-11-01
Gentamicin Sulfate
Dosage: 450 mg
Start date: 2010-11-02
End date: 2010-11-04
Inspra
Dosage: 25 mg
Administration route: Oral
Indication: Congestive Cardiomyopathy
End date: 2010-11-11
Micardis
Dosage: 80 mg
Administration route: Oral
Indication: Congestive Cardiomyopathy
End date: 2010-11-05
Vancocin Hydrochloride
Dosage: 750 mg
Indication: Staphylococcal Sepsis
Start date: 2010-10-31
End date: 2010-11-01
Other drugs received by patient: Lasix; Digoxin; Bisoprolol Fumarate
Possible Inspra side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: male
Reactions: Blood Testosterone Decreased, Blood Triglycerides Increased
Drug(s) suspected as cause:
Inspra
Dosage: unk
Start date: 2012-01-23
Protonix
Dosage: unk
Start date: 2012-01-23
Possible Inspra side effects in 94 year old male
Reported by a physician from Russian Federation on 2012-03-30
Patient: 94 year old male
Reactions: Cardiac Failure Chronic, Dyspnoea, Quality of Life Decreased
Drug(s) suspected as cause:
Inspra
Dosage: 25 mg, 1x/day
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2011-12-01
End date: 2012-03-01
Inspra
Indication: Cardiovascular Insufficiency
Other drugs received by patient: Diuver; Diuver; Metoprolol; Cardiomagnyl; Kardiket; Kardiket; Digoxin; Pradaxa
Possible Inspra side effects in 94 year old male
Reported by a physician from Russian Federation on 2012-03-28
Patient: 94 year old male
Reactions: Dyspnoea, Cardiac Failure Chronic, Quality of Life Decreased
Drug(s) suspected as cause:
Inspra
Dosage: 25 mg, 1x/day
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2011-12-01
End date: 2012-03-01
Inspra
Indication: Cardiovascular Insufficiency
Other drugs received by patient: Cardiomagnyl; Kardiket; Kardiket; Metoprolol; Diuver; Diuver; Pradaxa; Digoxin
Possible Inspra side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient: male
Reactions: Weight Increased, Drug Ineffective, Expired Drug Administered
Drug(s) suspected as cause:
Inspra
Dosage: 25 mg, unk
Start date: 2012-01-24
Lasix
Dosage: 30 mg, 1x/day
Start date: 2012-01-24
Lasix
Dosage: 100 mg, 1x/day
Possible Inspra side effects in
Reported by a consumer/non-health professional from United States on 2012-03-23
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Amiodarone HCL
Dosage: unk
Amiodarone HCL
Dosage: unk
Eplerenone
Dosage: unk
Erythrocin
Dosage: unk
Erythromycin
Dosage: unk
Erythromycin Stearate
Dosage: unk
Inspra
Dosage: unk
Possible Inspra side effects in male
Reported by a consumer/non-health professional from Canada on 2012-03-22
Patient: male
Reactions: Prostatic Specific Antigen Increased, Drug Intolerance, Cognitive Disorder
Drug(s) suspected as cause:
Inspra
Dosage: 12.5 mg, unk
End date: 2011-10-01
Inspra
Dosage: 25 mg, unk
Indication: Hyperaldosteronism
Start date: 2011-06-01
Possible Inspra side effects in 94 year old male
Reported by a physician from Russian Federation on 2012-03-19
Patient: 94 year old male
Reactions: Cardiac Failure Chronic, Dyspnoea, Quality of Life Decreased
Drug(s) suspected as cause:
Inspra
Indication: Cardiovascular Insufficiency
Inspra
Dosage: 25 mg, 1x/day
Administration route: Oral
Indication: Cardiac Failure Chronic
Start date: 2011-12-01
End date: 2012-02-01
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